Transparency Statement

This document serves as the Transparency Statement of the European Union's public-private partnership IDERHA – we aim to improve clinical decision-making and enhance patient access to health innovations through better use of health data.

This Transparency Statement defines the procedures concerning the flow, communication, and dissemination of information, data, and findings. In today's interconnected world, trust and transparency are fundamental pillars for fostering collaboration and achieving shared goals. This document serves as a commitment to uphold these principles within the framework of IDERHA, ensuring that all discussions, decisions, and actions are conducted with openness, honesty, and accountability.

At the heart of our Transparency Statement lies the belief that meaningful progress can only be achieved through inclusive and informed dialogue. We recognize the importance of engaging with a diverse range of stakeholders, including the public and especially patients, industry partners, government entities, regulatory bodies, healthcare professionals, and researchers. Through frequent consultation and active participation of these stakeholders, we aim to harness collective expertise, foster innovation, and address emerging challenges in the digital health sector.

In line with our commitment to transparency, IDERHA rejects the notion of closed-door negotiations and prioritizes open communication channels that promote trust and accountability. By sharing information openly and proactively, we aim to build a culture that strengthens partnerships, enhances decision-making processes, and ultimately benefits society as a whole. 

This Transparency Statement should be considered a living document: we welcome feedback on gaps, errors, and inconsistencies, as we plan to update the Transparency Statement regularly.

Many of our communication and dissemination tools, as described in the overview document listing these tools (available on Zenodo), directly or indirectly contribute to our transparency and accountability goals. Internal tools like Slack, SharePoint and Teams enable open discussions and easy information sharing among IDERHA partners, whereas external channels like the IDERHA website, newsletter, Project Brochure, Project Abstract, LinkedIn and YouTube channel keep stakeholders informed about progress and developments.

In addition, through regular webinars and workshops, IDERHA aims to both inform the public about progress and developments in the project, as well as seek its opinion on key topics concerning data access and data (re)use in health care and health research. The dedicated Outreach section on the website has a page on Workshop Flash Reports, summarizing past workshops and webinars. Public webinar and workshop recordings will be published on our YouTube channel. In addition, a regularly updated FAQ section on the website provides answers to common questions the public might have on IDERHA. To this end, we also organize a Public Forum (see below). 

Regular surveys and feedback forms are shared both internally as well as externally to collect and address concerns and suggestions from partners, stakeholders, and the public. Results of these surveys are discussed in the responsible Work Packages and when deemed necessary shared with the Management Board. 

In IDERHA, we fully embed the Open Science principles advocated by the Innovative Health Initiative (IHI). We adhere to the FAIR data principles, ensuring our research data is findable, accessible, interoperable, and reusable. Our publications are made openly accessible in peer-reviewed journals.

Next to this, all Public Deliverables and all publicly available documents and research output will be published on the open science repository Zenodo in our IDERHA Community. 

In addition, the IDERHA consortium members organize a series of workshops for project participants to educate and facilitate exchanges about topics and developments impacting the project. Conversely, regular webinars will be organized to inform the public and to seek their feedback on our work. 

IDERHA is committed to incorporate outside experiences, expertise and concerns into its work. To ensure this, we created several boards to give input to our technical teams and the researchers making policy-recommendations, and we organize consultation events and public fora to exchange ideas. 

Patient Advisory Board

For engagement with patients, the project connects through the Patient Advisory Board (PAB). The PAB currently consists of 13 members, including patients and patient representatives, and meets at regular intervals. The PAB’s role is broadly defined to monitor and review IDERHA activities from a patient perspective and help create meaningful patient involvement and input throughout the project. For selecting the candidates, the European Patients' Forum (EPF) opened a call of interest shared within the EPF and Lung Cancer Europe (LuCE) networks as well as on the IDERHA website. 

The candidates completed a survey explaining their expertise and motivation to join. Afterwards, EPF internally discussed the results and selected a shortlist of candidates that best aligned with the project objectives and needs. Interviews with the shortlisted candidates were conducted, and the final candidates were selected. Subsequently, the memorandum of understanding was sent to the participants, and an introductory session was held where the project and the PAB's role were explained in detail.

Clinical Advisory Board

As IDERHA aims to set up, pilot and run a pan-European health data platform focusing on lung cancer screening and (early-stage) non-small cell lung cancer care, it was clear that a multi-faceted Clinical Advisory Board (CAB) should be assembled. 

The goal is to make a multi-professional board including internal to IDERHA and external opinion leaders in the field of lung cancer, AI/ML specialists, an IT specialist, a PROM/PREM specialist, a patient representative, and healthcare authority representative. The clinical advisory board is set up to monitor and comment on the clinical use case project plans, to interpret the results and experiences of the use case projects, to assess and report on the clinical practicality and impact of the IDERHA platform, to suggest adaptions of the IDERHA platform from the clinical perspective and to provide counselling of IDERHA consortium partners regarding clinical aspects (throughout the entire project time). CAB online meetings will be held at least every 2 months and relevant IDERHA members will be asked to participate.

Each advisory board member is selected through a meticulous process that aims to include diverse and competent members who can contribute effectively to their respective areas. IDERHA generated a list of potential candidates for the CAB that are experts and specialists in lung cancer, PROM/PREM, AI/ML IT-/Network, EMA other healthcare authority representatives, and patient representatives. Invitations (as well as explanatory information on IDERHA, platforms, CAB roles, tasks, etc.) were sent out to the candidates. Willing CAB member acceptance was confirmed via email. The board was completed once the required number and roles/sections were filled. 

Currently, the completed CAB board is made up of external lung cancer KOLs (3 members); AI/ML specialists (6 members); PROM/PREM specialist (1 member); patient representative (1 member); IT specialists (2 members), and EMA or other healthcare authority representative (1 member).

Ethics Advisory Board

IDERHA is forming an Independent Ethics Advisory Board (EAB) that is composed of several experts in the areas of regulatory compliance, information security, ethics and interventional studies related to data driven research innovation in health in addition to patient representatives.

All EAB members are independent of the project and its partners, and their role is to oversee and review IDERHA’s activities, ensuring that the project overall operates within high standards of data protection compliance and ethics. The EAB will operate in combination with any Research Ethics Committee approvals IDERHA sponsored studies obtain and will provide an overall view of the project and its associated studies to help guide and assist IDERHA in ensuring that it meets its obligations to its participants, its partners and the wider public in terms of ethics and transparency around the use of data.

The EAB will meet at least once per year, preferably face to face aligned with the consortium meeting. As the EAB’s role is crucial in ensuring that the use of novel technologies in a rapidly evolving regulatory framework will make a meaningful impact on care outcomes and patient experience, the EAB can meet more often per year as deemed required, so a high standard of ethical and regulatory compliance can be achieved.

Integrated Data Access Governance Council

To help advance IDERHA’s goal of policy development, an Integrated Data Access Governance Council (IDAGC) is established.  IDAGC provides expert guidance to advance policy development that enables the ethical and trustworthy use of high-quality heterogeneous health data for research. Its mission is to: 

• Leverage their diverse expertise to develop consensus-driven policy recommendations that balance the interests of patients, healthcare systems, researchers, and other stakeholders. 
• Engage broadly with stakeholders to understand different perspectives and potential barriers to drive meaningful and adoptable policies. 
• Integrate input from IDERHA work packages, patient advisory groups, subject matter experts, and research to ensure recommendations are comprehensive and evidence-based. 
• Provide strategic oversight to shape policies that uphold data privacy, security, and governance while unlocking the potential of health data to drive innovations that improve human health.

The IDAGC includes approximately 6 senior leaders and experts who represent the perspectives of key stakeholder groups (e.g., Health Authorities, HTA organizations, patients, health systems, professionals, researchers, and industry). Other senior leaders and experts will be included in the IDAGC if specific competences are needed at specific times in the project period. Ad hoc experts can be both consortium members and non-consortium members. IDAGC members will be chosen based on their experience, expertise, and ability to represent the perspectives of key stakeholder groups. The IDAGC is co-chaired by a representative from a regulatory authority (the Danish Medicines Agency) and a representative from a patient organization European Patients’ Forum (EPF).

Public Consultations

In our pursuit of transparency and inclusive decision-making, IDERHA hosts regular public consultations in meetings, video conferences, and web forms. We will present general feedback from the consultations in webinars and reports. Broad participation is invaluable as we endeavor to develop policy recommendations that reflect the diverse needs and perspectives of our stakeholders.

Public Forum 

As part of our commitment to transparency and stakeholder engagement, IDERHA organises an annual Public Forum. This forum provides an open platform for participants to contribute their perspectives on critical issues surrounding data (re)use, access, and sharing in healthcare. 

Attendees have the opportunity to hear about IDERHA’s latest progress and challenges, as well as actively participate in discussions on topics such as the integration of AI in the care pathway, technical challenges in health data integration, and policy shaping for future needs. 

As an IHI project, IDERHA adheres to the principles described in the Data Sharing Playbook from the Innovative Health Initiative (IHI). It’s a comprehensive guide designed to facilitate effective data sharing practices among stakeholders in health research and innovation. It provides detailed guidelines, best practices, and practical steps to ensure that data sharing is conducted in a secure, ethical, and efficient manner, enhancing collaboration, and maximizing the benefits of shared data. 

By applying the guidelines of the playbook, IDERHA ensures compliance and commitment to high standards in data sharing. The playbook is accessible on the IHI website and serves as an essential resource for organizations involved in health-related projects, aiming to foster a more open and collaborative research environment. and serves as an essential resource for organizations involved in health-related projects, aiming to foster a more open and collaborative research environment.

Data Management Plan

We follow robust data management practices, including creating a comprehensive Data Management Plan (DMP), available on Zenodo in due time. This DMP also includes a Data Protection Policy (DPP) and Data Use Declarations (DUD), which will be made publicly available in due time.

The DMP is crucial for outlining the methods of data collection, storage, and use, ensuring that all data handling is conducted responsibly and in accordance with regulatory requirements, thereby supporting the project's integrity and compliance. The Data Sharing Playbook and the Data Management Plan together serve as essential resources for our project and stakeholders, aiming to foster an open and collaborative research environment.

Data security in the project is stringently upheld through several robust measures. Firstly, all patient data is strictly pseudonymized, ensuring that individual identities, such as names or addresses, are not accessible, thereby preserving confidentiality. Furthermore, to enhance data protection, no data is transferred outside the original data-holding organization. 

The project adopts a decentralized data analysis approach, where algorithms and analyses are executed within the secure environment of each data-holding organization itself. This method minimizes the risk of data breaches and ensures that all data handling complies with the highest standards of data security.

Use of Artificial Intelligence in IDERHA

IDERHA develops Artificial Intelligence and Machine Learning (AI/ML) models to predict a patient’s risk of developing lung cancer at various stages using various data types. The models are trained on real-world digital health record data and CT scans from multiple Spanish hospitals and the Finnish national health registry, ensuring a representative dataset. 

To mitigate bias, the models are trained on data from diverse sources, evaluated on independent data, and the age, sex, and ethnicity distributions are analysed. 

As an exploratory research study, IDERHA does not seek regulatory approval for the AI/ML algorithms. However, the project upholds ethical principles by obtaining independent ethics review and governance oversight at participating sites, adhering to data protection regulations, and upholding participants' rights. Public engagement is facilitated through transparent communication, such as this statement, and providing contact points for inquiries.

In all of IDERHA's engagement with non-project members, we are aware of the need for consent. We never assume consent when issues around use of personal data, photographs, video, and other privacy-sensitive topics might arise. A Participant Information Leaflet (PIL), to be shared before webinars, workshops, events, and other gatherings, will be made available.

In all public video webinars, it is stated beforehand that the meeting will be recorded, and that participants have the option to leave or re-enter under a pseudonym and with the camera switched off. 

During public meetings, it is stated beforehand that photographs might be taken, and that there might be a video recording, if applicable. 

For all occasions where there is a recording (audio, video, or both), non-IDERHA participants will be asked to sign a consent form. Templates for different audiences and occasions will be made available. 

On our website, a Privacy Policy covers the collection, processing and use of personal data, including data collected through the website. It also explains what data visitors may provide through the website when they sign up to our newsletter or submit an inquiry or comment.